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Dr. Tagawa discusses the incidence and identification of FGFR alterations in bladder cancer, the approval and use of erdafitinib in the second-line setting for patients with advanced bladder cancer, and research directions with the FGFR inhibitor in the field.
Welcome to OncLive On Air®! I’m your host today, Jessica Hergert.
OncLive On Air® is a podcast from OncLive®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive® covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.
In today’s episode, sponsored by Janssen, we had the pleasure of speaking with Scott T. Tagawa, MD, MS, FACP, a professor of medicine and urology at Weill Cornell Medical College, an attending physician at NewYork-Presbyterian Hospital, and medical director of the Genitourinary Oncology Research Program at Weill Cornell Medicine, to discuss FGFR testing and treatment with erdafitinib (Balversa) in metastatic bladder cancer.
On April 19, 2019, the FDA granted an accelerated approval to erdafitinib for the treatment of patients with locally advanced or metastatic bladder cancer with an FGFR3 or FGFR2 alteration that has progressed on platinum-containing chemotherapy, representing the first targeted therapy approved for metastatic bladder cancer.
The QIAGEN therascreen® FGFR RGQ Reverse-transcription-polymerase chain reaction (PCR) Kit was also approved as a companion diagnostic for use with erdafitinib.
The approval was based on findings from the phase 2 BLC2001 trial (NCT02365597), in which erdafitinib led to an overall response rate (ORR) of 32.2% in patients with FGFR2/FGFR3-positive locally advanced or metastatic bladder cancer. Responders included patients who had been unresponsive to anti—PD-1/PD-L1 treatment.
The median duration of response was 5.4 months (95% CI, 4.2-6.9). Among 64 patients with an FGFR3 point mutation, the ORR was 40.6% (95% CI, 28.6%-52.7%) and the ORR was 11.1% (95% CI, 0%-25.6%) among 18 patients with an FGFR3 fusion.
The most common all-grade adverse effects (AEs) were increased phosphate (76%), stomatitis (56%), fatigue (54%), increased creatinine (52%), diarrhea (47%), dry mouth (45%), onycholysis (41%), increasednalanine aminotransferase (41%), increased alkaline phosphatase (41%), decreased sodium (40%), decreased appetite (38%), decreased albumin (37%), dysgeusia (37%), decreased hemoglobin (35%), dry skin (34%), increased aspartate aminotransferase (30%), decreased magnesium (30%), dry eye (28%), alopecia (26%), palmar-plantar erythrodysesthesia syndrome (26%), constipation (28%), decreased phosphate (24%), abdominal pain (23%), increased calcium (22%), nausea (21%), and musculoskeletal pain (20%).
Common grade 3 or greater AEs included onycholysis (10%), stomatitis (9%), palmar-plantar erythrodysesthesia syndrome (6%), and paronychia (3%).
The accelerated approval of erdafitinib in bladder cancer is contingent on the results of a confirmatory trial.
In our exclusive interview, Tagawa discussed the incidence and identification of FGFR alterations in bladder cancer, the approval and use of erdafitinib in the second-line setting for patients with advanced bladder cancer, and research directions with the FGFR inhibitor in the field.
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